Kornimate/medical-research-clean huggingface dataset:
biological and psychological health effect of ramadan study

Conditions: Quality of Life

Summary: this observational study collects data on blood neurotransmitter and neuromodulator levels of subjects observing ramadan. additional information collected are a diet record, mood and perceived stress using validated surveys at three time points: a) before starting ramadan, b) at the midpoint evaluation, and c) at the end of ramadan. three additional dispositional factors collected at the beginning and at the end are: a) sense of belonging, b) purpose in life (sense of coherence), and c) empathy (interpersonal reactivity index). the subjects are also individually interviewed on their experience of ramadan as narrative data.

this is an observational study seeking research volunteers during ramadan in the pacific northwest. we plan to recruit 10 female and 5 male volunteers. each subject will donate her/his blood (20 milliliters) at three time points: a) before initiation of ramadan, b) 14 days later, and c) 30 days later (60 milliliters total over one month). because the dates of ramadan in 2021 occur on april 12th through may 11th, the three days of the blood collection will be april 10th, april 27th and may 11th ± 1 day. due to current covid-19 restrictions, mass gatherings at mosque do not happen. this study deploys a mobile phlebotomist who is a licensed healthcare practitioner who will set up a droplet barrier phlebotomy station. the time of phlebotomy is determined based on the hydration status of each individual. the specimens will be packed in an ice cooler and processed (centrifuged and divided into aliquots) at bastyr university tierney laboratory and stored in a -80 degree celsius freezer until analyzed at the same time for the three time points. narrative data will also be collected through individual conversations (phone or in-person) at the completion of ramadan, reflecting on the study and any heightened sense of spirituality.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age at the time of baseline blood draw, up to 65 years old * community member who observe ramadan during april 12 (monday evening) through may 11, 2021 (tuesday sundown) * understand and sign the informed consent form and have ability to comply with the requiremnets of the study * vaccinated for covid or having a history of a positive pcr test which was resolved exclusion criteria: * anticubital vein is not accessible * pregnant, breastfeeding, recovering from major illness or surgery that influences quality of life * who reside more than 14 miles away from the city limits * unavailable to meet in-person and donate blood for any of three measurement days (basline, 15th day, post ramadan) * smoking, drinking aclohol or using recreational drug * presence of a condition that in the opinon of the investigator would compromise the safety of the participant or the quality of the data
phase iii study comparing the efficacy and safety of la-ep2006 and neulasta®

Conditions: Neutropenic Complications; Breast Neoplasms; Chemotherapy-induced Neutropenia; Chemotherapeutic Toxicity

Summary: the study will assess the efficacy of la-ep2006 compared to neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

this randomized, double-blind trial compared the proposed biosimilar la-ep2006 with the reference neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. therefore patients were randomized to receive la-ep2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant tac (docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) chemotherapy. the primary end point was the duration of severe neutropenia (dsn) during cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9/l). the equivalence was confirmed if 95% cis were within a ±1 day margin. la-ep2006 was equivalent to the reference product in dsn (difference: 0.07 days; 95% ci \[-0.12, 0.26\]). further, la-ep2006 and the reference neulasta® showed no clinically meaningful differences regarding efficacy and safety.

Eligibility criteria:
inclusion criteria: * histologically proven breast cancer * eligible for six cycles of neoadjuvant or adjuvant chemotherapy exclusion criteria: * concurrent or prior chemotherapy for breast cancer * concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy * concurrent prophylactic antibiotics * previous therapy with any g-csf (granulocyte-colony stimulating factor) product other protocol-defined inclusion/exclusion criteria may apply.

Keywords: biosimilars pegfilgrastim, g-csf, neutropenia, breast cancer, myelosuppressive chemotherapy, supportive care granulocyte-colony-stimulating factor
ethanol lock and risk of catheter related blood stream infection in patients with haemodialysis catheter

Conditions: Hemodialysis Catheter-Associated Bacteremia; Hemodialysis Complication

Summary: the aim of this study is to examine the effect of ethanol (70%) as lock-solution after hemodialysis on: * the frequency of dialysis catheter-related bacteremia among patients under observation of potential complications * other complications of the use of hemodialysis-catheters eg. dysfunction of the catheter due to thrombosis.


Eligibility criteria:
inclusion criteria: * age at or above 18 years. * currently recieving hemodialysis treatment with tunneled intravenous hemodialysis-catheter * written informed consent after verbal and written information is given. exclusion criteria: * pregnancy or breastfeeding * intolerance to ethanol or contraindications for the use of ethanol. eg. possible interactions, former alcohol dependency. * earlier infections to current catheter (exit-site, tunnel-infection and catheter-related bloodstream infection
evaluation of alpha-lipoic acid in diabetic cardiomyopathy

Conditions: Diabetic Cardiomyopathies

Summary: the heart has the ability to respond to different patho-physiological conditions by adapting its energy metabolism. in diabetic subjects, the myocardium uses only fatty acids as a substrate. this is the cause of diabetic cardiomyopathy (dcm). the activation of the transcription factor pparβ/δ allows a good use of fatty acids. the staff have demonstrated that alpha lipoic acid (aαl), a molecule with antioxidant properties present in food supplements and in certain foods (broccoli, cabbage, offal...), induces the expression of pparβ/δ in skeletal muscle and thus increases the activity of this transcription factor.


Eligibility criteria:
inclusion criteria: * male or female adult age ≥ 18 years * patient with diagnosed type 2 diabetes (history of pathological hyperglycemia according to who and hba1c standards \>7% or ongoing treatment with oral antidiabetic agents). * patients with stable cardiomyopathy (no hospitalization in cardiology in the month before inclusion) with a left ventricular ejection fraction (lvef) \<50%. * patient who has signed an informed consent form * for women of childbearing age: effective contraception followed for at least 3 months before the start of the study and agreeing to keep it for the duration of the study. * affiliation to a social security scheme. exclusion criteria: subjects: * with a coronary event in the year before inclusion. * with symptoms of cardiac ischemia at inclusion. * pregnant or breastfeeding woman * severe renal insufficiency * using antioxidant molecules in the 6 months prior to inclusion. * using drugs that can activate ppars (fibrates, telmisartan, enalaprilat). * using anti-inflammatory drugs. * suffering from acute infectious diseases and inflammatory diseases. * hypersensitivity or a history of hypersensitivity reaction to gadoteric acid, meglumine or any drug containing gadolinium. non-inclusion criteria related to mri: * with an implanted vascular stent less than 6 weeks before the examination; * carrier of an implanted biomedical device deemed "not safe" or "unsafe" in the list: http://www.mrisafety.com/thelist_search.asp; * beneficiary of an acquisition procedure that does not respect the conditions required by "conditional" use in a subject carrying an implanted biomedical material considered "conditional" in the list: http://www.mrisafety.com/thelist_search.asp; * carrier of a ferromagnetic intraocular or intracranial foreign body close to the nerve structures; * carrying biomedical equipment such as a cardiac, neural or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained to perform mri in these subjects;
phase ii clinical trial of alemtuzumab to treat b-cell chronic lymphocytic leukemia

Conditions: B-cell Chronic Lymphocytic Leukemia

Summary: this is a phase ii, prospective, multicenter, open-label study to evaluate the efficacy and safety of alemtuzumab in patients with relapse and refractory b-cell chronic lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * an established diagnosis of b-cell chronic lymphocytic leukemia(b-cll) * meet criteria of relapsed or refractory cll * presence of one or more measurable lesions * ecog score 0-1 * life expectancy \> 3 months * female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy. exclusion criteria: * less than 2 weeks from prior anti-cancer therapy. * allergic to the antibody or any component of the investigational product. * other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (class iii or iv), uncontrolled diabetes. * use of investigational agents rather than alemtuzumab. * active systematic infection or major organ malfunction requiring treatment. * serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or serum alanine aminotransferase (alt) and/or serum aspartate aminotransferase (ast) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or alt and/or ast greater than or equal to 5 times upper limits of normal (liver metastases). * blood urea nitrogen(bun) greater than or equal to 1.5 times upper limits of normal or serum creatinine greater than or equal to 1.5 times upper limits of normal. * white blood cell(wbc) count\< 3.5×109/l or absolute neutrophil count(anc)\<1.5×109/l or platelet count\<75×109/l or hemoglobin\<80g/l. * human immunodeficiency virus (hiv) positive. * active hepatitis or a history of prior viral hepatitis b or c, or positive hepatitis b serologies without prior immunization. * pregnant or nursing women. * known central nervous system(cns) metastases with b-cll. * active secondary malignancy. * cytomegalovirus(cmv) positive or immunodeficiency disease or after stem cell transplantation.

Keywords: alemtuzumab b-cell chronic lymphocytic leukemia cd52
relationship between muscle strength and physical function in icu

Conditions: Critical Illness; Muscle Weakness; Physical Disability; Physical Dependence

Summary: this observational study aims to assess the relationship between muscle strength and physical function in critical ill patients. grip and quadriceps strengths are measured using a standardized protocol of dynamometry. physical function is assessed using the validated icu mobility scale.


Eligibility criteria:
inclusion criteria: * icu stay of at least 48h * collaborative (rass score -1 to +1) exclusion criteria: * refusal * coma * non collaborative * hemi / tetra paresis or plegia
non-invasive pulmonary artery prediction (adopts)

Conditions: Heart Failure; Pulmonary Arterial Hypertension

Summary: a proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (pap), a physiologic marker of cardiopulmonary function. the algorithm was developed from pap recordings obtained during invasive right heart catheterization. the study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records ekg, heart sounds, and thoracic impedance has yet to be established.

a prototype device will be supplied by silverleaf medical science (redlands, ca) to record these signals. this study will take place at loma linda va, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. the investigators will screen and enroll 20 veterans who consent to participate in the study. veterans who decline to consent and vulnerable populations will be excluded from the study. the investigators will obtain simultaneous recordings from the prototype device (ekg, heart sounds, and thoracic impedance) and from the pap catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and valsalva (1 minute recordings with 1-minute breaks). de-identified recordings from the prototype device will be shared with the team at silverleaf medical science to derive a computed pap. the investigators will test the hypothesis that computed pap is no different than measured pap. if the algorithm can produce a computed pap with high accuracy,'\[it would be the first wearable system to non-invasively report pap.

Eligibility criteria:
inclusion criteria: * written informed consent and authorization to use and disclose health information. * 20 years of age or older. * diagnosis of hf for \>3 months, with preserved or reduced left ventricular ejection fraction (lvef). * female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial. exclusion criteria: * active infection. * unable to tolerate a right heart catheterization (rhc), in the investigator's opinion. * implantation of cardiac resynchronization therapy (crt)\<3 months before enrollment. * enrolled in concurrent studies that may confound the results of this study. * clinical condition that would not allow them to complete the study, in the investigator's opinion.

Keywords: pulmonary artery pressure electrocardiogram heart failure machine learning
kidney function after pneumoperitoneum and analgesia

Conditions: Laparoscopic Cholecystectomy

Summary: double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac

background: the laparoscopic cholecystectomy (lc) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. this prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to lc, using creatinine (cr), cystatin c, and enzymuria evaluations. methods: in the pre- and postoperative (po) periods, estimated glomerular filtration rates (gfr), obtained from two formulas dependants of blood cr and one from blood cystatin c values, and tubular enzymuria - alkaline phosphatase (ap), γ-glutamyltransferase (γ-gt) - were determined in patients who underwent lc and analgesia with tramadol and dipyrone (g1, n=63) or tramadol and ketorolac (g2, n=63). in the recovery room (rr), pain and need of rescue analgesia with morphine were evaluated.

Eligibility criteria:
inclusion criteria: * from 18 to 60 years * normal kidney function * free consented participation exclusion criteria: * renal and hepatic dysfunction * prior (one month) use of anti-inflammatory agents

Keywords: kidney function tests anti-inflammatory agents, non-steroidal laparoscopic cholecystectomy adult
assessment of airway responsiveness and treatment efficacy in asthmatics

Conditions: Asthma

Summary: bronchial asthma is a common chronic respiratory disease. patients usually manifest variable symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow limitation and often associated with airway hyper-responsiveness and airway inflammation. about 1-18% of the global population suffered from the disease, causing huge economic burden for patients and countries. airway reactivity measurement is an important way of diagnosis of asthma. methacholine (mch) bronchial provocation test(bpt) is the "gold standard" for the determination of airway reactivity, and other measuring methods(like adenosine monophosphate(amp)-bpt, leukotriene d4(ltd4)-bpt, astograph-bpt, etc.) were also brought into hot research fields. the investigators' purposes were to compare different kinds of methodologies(mch,amp,ltd4-bpt, astograph-bpt) assessing airway responsiveness and to investigate treatment efficacy of budesonide /formoterol in asthmatics.

this study composed of two parts, that were the diagnosing part and the treatment part.

Eligibility criteria:
inclusion criteria: * clinically diagnosed asthmatic patients aged from14 to 65 years； * had a had a normal chest radiographic result； * had a baseline spirometry with the forced expiratory volume in one second (fev1) of not less than 60% predicted； * without acute upper respiratory tract infection for the past 2 weeks exclusion criteria: * smokers； * had a poor cooperation to the test or limited understandings; * had a past confirmed history of respiratory disease other than bronchial asthma (copd, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）; * pregnancy or breast-feeding women; * taken related drugs before measurements（leukotriene receptor antagonists (ltra) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）
use of ketamine in severe pain syndromes

Conditions: Pain, Intractable; Pain, Chronic; Pain Syndrome; Pain Measurement

Summary: ketamine has been shown to have a certain efficiency in chronic pain syndromes. however, it is still not clearly known what is its efficiency and how ketamine is used in real world patients. in this retrospective study, all patients treated with ketamine for chronic pain in our hospital will be reviewed. patients demographics, pain syndromes as well as outcome criteria will be collected to describe the use of ketamine in pain syndromes.

the american society of regional anesthesia and pain medicine, together with the american academy of pain and the american society of anesthesiologists published a consensus guideline in 2018 on the use of ketamine in chronic pain. a review of medical charts of all patients who received ketamine for chronic pain between january 2010 and june 2024 will be done. demographic data, detailed pain scores, as well as description of the type of pain will be collected. ketamine usage will be recorded for the dosage, as well as duration of the treatment. outcome will be measured by before/after pain scores for neuropathic pain, as well as on a visual analog scale. a more global score (good-medium-no effect) will also be collected to get the patient's impression on their treatment. concomitant pain medication will be collected.

Eligibility criteria:
inclusion criteria: - all patients who received ketamine as treatment for a pain syndrome during january 2010 until june 2024 at erasme university hospital exclusion criteria: * age \< 18 years * patients who expressed their opposition to the use of their medical data * incomplete medical chart
a study of clinical outcomes for the nanostring® technologies prosigna™ gene signature assay

Conditions: Breast Cancer

Summary: the primary objective of this study is to evaluate the impact of the result of the prosigna test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

the secondary objectives will consist of: * the evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers * the evaluation of the rate of secondary effects of chemotherapy, * the evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the prosigna test (assay) results

Eligibility criteria:
inclusion criteria: * resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0) * estrogen receptor status will be evaluated by immunohistochemistry (ihc) and more than 1% of stained tumor cells will be considered positive. * her2 status will be evaluated by ihc (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. * postmenopausal women defined as: * natural amenorrhea \> 12 months, regardless of age * bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) * radiological castration with amenorrhea \> 3 months, regardless of age * hysterectomy and postmenopausal blood levels * able to give consent * eligible for treatment of breast cancer with adjuvant chemotherapy * ecog performance status of 0 or 1 exclusion criteria: * tumor size t3-t4 * non-invasive breast cancer (e.g., paget's disease, dcis) * tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+) * tumors that are estrogen-receptor negative or her2 positive * have metastatic disease * unable to give informed consent * unable to complete patient reported outcome surveys * have contraindications for adjuvant chemotherapy * age, performance status, significant comorbidities * ecog performance status \> 1
efficacy and safety of the combination aliskiren (300 mg) and hydrochlorothiazide (25mg) to aliskiren (300mg) monotherapy in patients with staged ii hypertension

Conditions: Hypertension

Summary: this study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with stage ii hypertension over a period of 12 weeks.


Eligibility criteria:
inclusion criteria: * outpatients ≥18 years of age. * patients with a diagnosis of stage ii hypertension, defined as mean sitting systolic blood pressure (mssbp) ≥ 160 mmhg and \< 180 mmhg at visit 2. exclusion criteria: * severe hypertension defined as mssbp ≥ 180 mmhg and/or mean sitting diastolic blood pressure (msdbp) ≥ 110 mmhg. * secondary form of hypertension. * current diagnosis of heart failure (new york heart association \[nyha\] class ii-iv). * current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates). * second or third degree heart block without a pacemaker. * concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to visit 1. * clinically significant valvular heart disease. * previous history of hypertensive encephalopathy or stroke, transcient ischemic attack (tia), heart attack, coronary bypass surgery or any pci. * known keith-wagener grade iii or iv hypertensive retinopathy. * in the month prior to visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications. * patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications. * inability to discontinue prior antihypertensive or other cv medications as required by the protocol. * patients with type 1 diabetes mellitus. * patients with type 2 diabetes mellitus not well controlled . * elevated serum potassium (over 5.3 meq/l (mmol/l). * any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: essential hypertension stage ii